Director, In Vivo Pharmacology

JOB PURPOSE

The Director, In Vivo Pharmacology will provide operational and scientific management for nonclinical tolerability, activity, and efficacy studies of drug candidates in the department of in vivo Pharmacology. The successful candidate will have strong drug development experience and be able to contribute across multiple therapeutic areas, will serve on cross-functional teams as an in vivo expert, will be responsible for overseeing and managing the conduct of in vivo personnel and studies to ensure scientific rigor, and demonstrate expertise on study process and specialist needs for cell and gene therapy products. The candidate will have strong communication and collaboration skills, demonstrated abilities as a manager related to ensuring career development and sustainable resourcing, and the ability to handle several multifaceted studies at once.

DUTIES AND RESPONSIBILITIES

• Effectively develop, manage, and track all aspects of in vivo non-GLP, non-clinical Cell and Gene Therapy studies
• Oversee qualification and selection of nonclinical CROs to support the nonclinical program in collaboration with Procurement and the Pharmacology and Toxicology Functional leadership
• Obtain quotes from CROs for pending nonclinical studies or support services including providing detailed study designs for RFPs; Work with Legal and contracts manager to ensure CDA/NDA, MSA, SOW, and POs are in place and tracked properly
• Interact on cross-functional teams and on project teams to represent in vivo pharmacology
• Write, Review, and oversee study protocols, coordinating cross-functional review and agreements
• Calculate and coordinate test article needs, coordinate across multiple departments for study support such as sample analyses (e.g. bioanalytical and pathology) and procedural aid
• Oversee and monitor internal and external in vivo studies to ensure proper dosing, execution and close of study activities, and generate monitoring reports for internal and QA review
• Formally present study design and data interpretation at internal group, department or Project Team meetings and where appropriate present externally at relevant scientific meetings
• Work fluidly with Core Team Project Manager and Program Team Lead (PTL) to update timelines as well as expectations and deliverables
• May be responsible for supervision of internal scientific staff or contracted staff (as needed)

QUALIFICATIONS

Basic Qualifications

• PhD or DVM with 8+ years of life sciences or industry experience, with at least 3 years of managing others in a matrixed environment.
• Experience with handling, dosing, and tissue collections from small and large animals and how to manage this through an outsourcing strategy
• Solid understanding of the 3R's and animal welfare regulations (USDA, OLAW, IACUC)
• Independently designs, executes and analyzes experiments and participates in scientific research strategies in collaboration with the lead scientists (e.g. pharmacology, bioanalytical, toxicology, and pathology)
• Must be detailed oriented, with ability to multi-task and work cross-functionally with team members and team environments.
• Effective communicator both verbally and in writing
• Excellent interpersonal, organizational and problem-solving skills required to manage multiple studies at different phases in parallel and track work and projects to meet timeline demands
• Must be proficient with MS Office (Word, Excel, PowerPoint, Project etc), Prism (basic statistics and graphing), and or project management software

Preferred Qualifications

• Expertise in T-cell biology, CAR-T therapies and their application
• Knowledge of the design and conduct of non-clinical pharmacology and or toxicology safety studies for the development of cell or gene therapies
• Experience working with CMC, Bioanalytical, Biostatistics, and Pathology partner lines both internal and external to support data generation and analyses for sub-reports
• Experience with drug development process, cross-functional interactions and team-based experience